Since nothing else is happening, let me bore you with a little background info. Many academic psychiatrists, particularly child and adolescent psychiatrists (known as CAPs), are under fire for being drug company shills. Three prominent Harvard CAPs were recently disciplined over charges that they failed to disclose that they were taking millions of dollars in "consulting fees" from pharmaceutical manufacturers for recommending that very potent (and expensive!) antipsychotics be given to children as young as two. So great is the influence of these CAPs that in the US (and nowhere else) the diagnosis of bipolar disorder among toddlers has increased 40X in the last decade. Fava, by contrast, has co-authored papers showing that escitalopram (Lexapro-about $130/month) is no more effective than a placebo in treating MDD, and is less effective than generic tianeptine ( Stablon-about $30/mo). Fava's demonstrated scientific neutrality gives his work added gravitas. So, assuming he does write something favorable about NSI-189, it will be taken very seriously even by those who are otherwise--and rightfully--skeptical of psychiatric pharmaceutical manufacturers. On the other hand, he will pull no punches if he's not convinced of its efficacy. Stand by. Any day now, something major will be released.
It really is depressing reading about antidepressant drugs. Reminds me of this 60 minutes episode. I quote:
Kirsch explained to 60 Minutes presenter Lesley Stahl that the “difference between drug and placebo is very, very small,” and “in half of the studies, non-existent.” Kirsch further explained that the purported efficacy of antidepressants is the result of a placebo effect -- not the chemical ingredients of the drug.
Kirsch only discovered the lack of antidepressant efficacy by accident while studying placebo effects. He was so shocked by the initial findings that he decided to do a second study, using data not only from published clinical trials funded by drug companies, but also from data submitted to the Food and Drug Administration (FDA), which he obtained through the Freedom of Information Act. The results were revealing.
“These are the studies that showed no benefit of the antidepressant over the placebo. What they did is they took the more successful studies, they published most of them. They took their unsuccessful studies and they didn't publish them," Kirsch explained.
In fact, one FDA official candidly explained: “How do we interpret ... two positive results in the context of several more studies that fail to demonstrate that effect?” As he explained, “I am not sure I have an answer to that, but I am not sure that the law requires me to have an answer to that – fortunately or unfortunately. That would mean, in a sense, that the sponsor [drug manufacturer] could just do studies until the cows come home until he gets two of them that are statistically significant by chance alone, walks them out and says he had met the criteria.” (Melody Petersen, Our Daily Meds (2008),
Sentiment: Strong Buy
Big Pharma has major credibility problems. As you pointed out, too often drug companies own the research data and get to pick and choose what is published. Another issue is financial conflicts of interest between researchers and the companies. A review of published studies of the anti-diabetic drug rosiglitazone (Avandia) found that 94 percent of authors who had written favorably about the drug had financial conflicts of interest, compared with 28 percent who had written unfavorably. Yet another major problem is "misbranding," or promoting a drug for unapproved uses. In 2012, GSK paid a $3 billion fine to settle civil and criminal charges that it had actively promoted its drugs for conditions for which their own data showed the drugs were ineffective. Finally, there's the issue that many drugs coming on the market are "me-too" drugs for which equally or more effective--and far less expensive!--generic drugs are readily available. Doctors give you free samples of the more expensive drugs, but rarely know their actual cost. If you're taking the anti-hypertensive drug olmesartan (Benecar), you're probably paying around $300 a month when the closely-related generic losartan would probably provide the same benefit for 1/10th the cost.
Good to know, thanks. It seems CUR has good standards (all bashers, here is your opening) that include the people they work with. I noticed that Garr is involved in a lot of charitable work especially for children. His writings also show a distaste for the high and mighty tactics used in the financial and pharmaceutical industry which somewhat explains the high negative targeting of CUR. Dr. Fava was a good choice by CUR for this review.